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Wii-Fit For Balance And Gait In Elderly Veterans

Primary Purpose

Gait, Unsteady, Postural Balance

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Wii-Fit exercises
Cognitive remediation exercises
Sponsored by
Central Arkansas Veterans Healthcare System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gait, Unsteady focused on measuring Balance, gait, Wii-Fit

Eligibility Criteria

60 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects age ≥ 60 years
  • Fall risk as measured by Berg Balance Scale (BBS) is ≤ 52
  • Normal cognition as measured by Mini Mental State Exam (MMSE ≥ 24)
  • Able to consent

Exclusion Criteria:

  • Subjects using wheel chair or walkers for mobility
  • Subjects with absolute contraindications per ACSM guidelines
  • Any medical condition (per the relative contraindications per ACSM guidelines below) that in the opinion of the study physician is likely to compromise their ability to safely participate in the exercise program.

Sites / Locations

  • Central Arkansas Veterans Healthcare System (3J/NLR)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Wii-Fit program

Cognitive remediation program

Arm Description

Wii-Fit exercises will be adminstered for 45 minutes 3 days a week for 8 weeks

Cognitive remediation exercises will be adminstered for 45 minutes 3 days a week for 8 weeks

Outcomes

Primary Outcome Measures

Berg Balance Scale
The primary efficacy outcome was the Berg Balance Scale (BBS), which assesses balance impairments in older adults and is a good measure of static and dynamic stability. It consists of 14 tasks performed in a standardized order with each task scored on a five-point scale according to quality or time ranging from "0" (lowest level of function) to "4" (highest level). The maximum score is 56. BBS has an excellent inter-rater reliability (0.98). A change of four points is considered the minimally detectable change for community dwelling older adults that ambulate without an assistive device.

Secondary Outcome Measures

Quality of Life (SF-36)
Functional Status Measures
Activities Specific Balance Confidence Scale
Modified Mini- Mental Exam

Full Information

First Posted
July 11, 2014
Last Updated
January 23, 2018
Sponsor
Central Arkansas Veterans Healthcare System
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1. Study Identification

Unique Protocol Identification Number
NCT02190045
Brief Title
Wii-Fit For Balance And Gait In Elderly Veterans
Official Title
Wii-Fit For Balance And Gait In Elderly Veterans
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central Arkansas Veterans Healthcare System

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Falls are a major public health problem. They are the leading cause of injuries and injury-related deaths in those aged over 65 years. Balance and gait abnormalities are major reasons for falls in elderly. Exercise interventions improve gait and balance in the elderly. Despite the many proven benefits of exercise, many older adults in the US remain sedentary. This study targets at improving balance and gait with use of Wii-Fit as an exercise program.
Detailed Description
Objectives/Rationale Falls are a major public health problem. They are the leading cause of injuries and injury-related deaths in those aged over 65 years. Balance and gait abnormalities are major reasons for falls in elderly. Exercise interventions improve gait and balance in the elderly. Despite the many proven benefits of exercise, many older adults in the US remain sedentary. This study targets at improving balance and gait with use of Wii-Fit as an exercise program. Specific aims To establish the safety, feasibility, and efficacy of an 8-week Wii-Fit program to improve measures of balance, and gait in older adults, compared to a cognitive remediation program, Brain fitness. To compare the effect of an 8-week Wii-Fit program to Brain fitness program, on measures of biomechanical assessment, adherence, safety, physical activity, fear of fall, enjoyment, functional status, cognition and quality of life. Design 8-week, randomized, parallel group, active intervention study Methods Patients will be recruited via IRB approved flyers posted in various locations of the Little Rock and North Little Rock CAVHS campuses and via referrals from the CAVHS providers. Thirty elderly Veterans will be randomly assigned to Wii-Fit arm or Brain fitness arm. Both groups will participate in the intervention for approximately 45 minutes 3 days a week for 8 weeks. Outcome measures will be assessed at baseline, and approximately week 4 and after completion of week 8. Balance and gait will be assessed by Berg Balance Scale. Secondary outcome measures include biomechanical testing for gait and balance, Safety, Adherence, measures of functional status, cognition, quality of life, fear of falling, physical activity and physical activity enjoyment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gait, Unsteady, Postural Balance
Keywords
Balance, gait, Wii-Fit

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Wii-Fit program
Arm Type
Experimental
Arm Description
Wii-Fit exercises will be adminstered for 45 minutes 3 days a week for 8 weeks
Arm Title
Cognitive remediation program
Arm Type
Placebo Comparator
Arm Description
Cognitive remediation exercises will be adminstered for 45 minutes 3 days a week for 8 weeks
Intervention Type
Other
Intervention Name(s)
Wii-Fit exercises
Intervention Description
Wii-Fit exercises will be administered for 45 minutes 3 days of the week for 8 weeks
Intervention Type
Other
Intervention Name(s)
Cognitive remediation exercises
Intervention Description
Cognitive Remediation exercises will be administered for 45 minutes 3 days of the week for 8 weeks
Primary Outcome Measure Information:
Title
Berg Balance Scale
Description
The primary efficacy outcome was the Berg Balance Scale (BBS), which assesses balance impairments in older adults and is a good measure of static and dynamic stability. It consists of 14 tasks performed in a standardized order with each task scored on a five-point scale according to quality or time ranging from "0" (lowest level of function) to "4" (highest level). The maximum score is 56. BBS has an excellent inter-rater reliability (0.98). A change of four points is considered the minimally detectable change for community dwelling older adults that ambulate without an assistive device.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Quality of Life (SF-36)
Time Frame
8 weeks
Title
Functional Status Measures
Time Frame
8 weeks
Title
Activities Specific Balance Confidence Scale
Time Frame
8 weeks
Title
Modified Mini- Mental Exam
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects age ≥ 60 years Fall risk as measured by Berg Balance Scale (BBS) is ≤ 52 Normal cognition as measured by Mini Mental State Exam (MMSE ≥ 24) Able to consent Exclusion Criteria: Subjects using wheel chair or walkers for mobility Subjects with absolute contraindications per ACSM guidelines Any medical condition (per the relative contraindications per ACSM guidelines below) that in the opinion of the study physician is likely to compromise their ability to safely participate in the exercise program.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kalpana Padala, MD
Organizational Affiliation
Central Arkansas Veterans Healthcare System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Arkansas Veterans Healthcare System (3J/NLR)
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72114
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28261500
Citation
Padala KP, Padala PR, Lensing SY, Dennis RA, Bopp MM, Parkes CM, Garrison MK, Dubbert PM, Roberson PK, Sullivan DH. Efficacy of Wii-Fit on Static and Dynamic Balance in Community Dwelling Older Veterans: A Randomized Controlled Pilot Trial. J Aging Res. 2017;2017:4653635. doi: 10.1155/2017/4653635. Epub 2017 Feb 5.
Results Reference
derived

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Wii-Fit For Balance And Gait In Elderly Veterans

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